DBV Technologies files a license application for VIASKIN® Peanut

DBV Technologies announced the filing of its Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for the VIASKIN® Peanut patch. This treatment is intended for children aged 4 to 7 years with peanut allergies. The application is based on the positive results of the VITESSE study, the largest to date in this population, and DBV has requested priority review.

The VIASKIN® patch uses epicutaneous immunotherapy, an innovative approach that requires neither injections nor oral administration. The FDA previously granted the patch Breakthrough Therapy designation, highlighting its potential.

This filing represents a crucial step for DBV Technologies, marking a milestone in its transformation into a commercial organization. The treatment could offer a non-invasive option for young patients suffering from food allergies.